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We enrolled participants of either sex aged years with inadequately controlled moderate-to-severe asthma for 12 months or more, requiring treatment with inhaled corticosteroids at a stable dose. We randomly assigned participants to receive tralokinumab mg or placebo by an interactive web-based system or voice response system. Participants and study personnel were masked to treatment allocation.
Both tralokinumab and placebo were administered subcutaneously every 2 weeks. The primary outcome measure was change from baseline to week 12 in bronchial biopsy eosinophil count. Secondary outcome measures included change in blood and sputum eosinophil counts. Safety analyses were carried out in all participants who received study drug. This trial is registered with ClinicalTrials.
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